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ScheBo Biotech Pancreatic Elastase 1 ELISA Stool Test - HSA Registration DE0509121

Access comprehensive regulatory information for ScheBo Biotech Pancreatic Elastase 1 ELISA Stool Test in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509121 and owned by ScheBo Biotech AG. The device was registered on March 28, 2024.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B IVD
DE0509121
ScheBo Biotech Pancreatic Elastase 1 ELISA Stool Test
HSA Registration Number: DE0509121
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Product Description

The ScheBo Pancreatic Elastase 1 ELISA Stool Test is an in-vitro diagnostic immunochemistry enzyme ELISA test intended for the quantitative measurement of pancreatic elastase 1, in human stool, to aid in the diagnosis of exocrine pancreatic insufficiency by healthcare professionals. Test results are to be used in conjunction with information obtained from patients' clinical evaluation and other diagnostic procedures.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0509121
Registration Date
March 28, 2024
Retention Due Date
March 27, 2026
Product Owner
Short Name
ScheBo Biotech AG
Address
Netanyastr. 3, 35394 Giessen, GERMANY
Registrant
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Importer
Address
400 ORCHARD ROAD, ORCHARD TOWERS, #12-05, SINGAPORE 238875
Model Information
Model Name(s)
ScheBo Extraction Buffer ScheBo Pancreatic Elastase 1 ELISA Stool Test ScheBo Master Quick-Prep
Model Identifier(s)
2 7 28-quick